PART I – BACKGROUND

The FFDCA and Public Health Service Act require that sponsors of FDA-regulated products submit evidence of their products safety in research and/or marketing applications. These products include food and color additives, animal drugs, human drugs and biological products, human medical devices, diagnostic products, and electronic products. FDA uses these data to answer questions regarding:

The toxicity profile of the article.

The observed no adverse effect dose level in the test system.

The risks associated with clinical studies involving humans or animals.

The potential teratogenic, carcinogenic, or other adverse effects of the article.

The level of use that can be approved.

The importance of nonclinical laboratory studies to FDAs public health decisions demands that they be conducted according to scientifically sound protocols and with meticulous attention to quality.

In the 1970s, FDA inspections of nonclinical laboratories revealed that some studies submitted in support of the safety of regulated products had not been conducted in accord with acceptable practice, and that accordingly data from such studies was not always of the quality and integrity to assure product safety. As a result of these findings, FDA promulgated the Good Laboratory Practice (GLP) Regulations, 21 CFR Part 58, on December 22, 1978 (43 FR 59986). The regulations became effective June 1979. The regulations establish standards for the conduct and reporting of nonclinical laboratory studies and are intended to assure the quality and integrity of safety data submitted to FDA.

FDA relies on documented adherence to GLP requirements by nonclinical laboratories in judging the acceptability of safety data submitted in support of research and/or marketing permits. FDA has implemented this program of regular inspections and data audits to monitor laboratory compliance with the GLP requirements.